CANDI: Cannabis and Thought Disorder in Schizophrenia

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Recruiting
CT.gov ID
NCT03608137
Collaborator
(none)
50
1
2
48.8
1

Study Details

Study Description

Brief Summary

Recent studies have suggested a strong relationship between cannabis use and the level of thought disorder in subjects with schizophrenia. Moreover, the level of thought disorder has been associated with an increased functional connectivity between the temporal lobe and the Putamen. However, the brain mechanisms underlying these two relationships are still poorly known. Better understanding these mechanisms is important to improve patients' care, in particular among treatment-resistant patients.

The objective of the CANDI study consists of assessing whether the level of cannabis use in patients with schizophrenia modulates the level of thought disorder via a modulation of the functional connectivity between the temporal lobe and the Putamen. Analyses will be controlled for the composition of cannabis, in particular the tetrahydrocannabinol / cannabidiol ratio.

Condition or Disease Intervention/Treatment Phase
  • Other: Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships
N/A

Detailed Description

25 subjects with schizophrenia and current cannabis use will be recruited in the experimental group. The control group will consist of 25 subjects with schizophrenia but with no cannabis use.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships
Actual Study Start Date :
Dec 7, 2018
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cannabis users

Subjects of this group have to meet the DSM-5 criteria for schizophrenia and smoke cannabis at least two days per week for every week of the past month. They have to exhibit negative urine screen for any substance except benzodiazepines and cannabis.

Other: Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships
To investigate whether the level of cannabis use in schizophrenic patients influences the symptoms of psychic disorganization via modulation of cerebral connectivity between the temporal lobe and the putamen.

Active Comparator: Non- cannabis users (control group)

Subjects of this group have to meet the DSM-5 criteria for schizophrenia and have to report no cannabis use over the previous month, and exhibit negative urine screen for any substance except benzodiazepines.

Other: Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships
To investigate whether the level of cannabis use in schizophrenic patients influences the symptoms of psychic disorganization via modulation of cerebral connectivity between the temporal lobe and the putamen.

Outcome Measures

Primary Outcome Measures

  1. Level of thought disorder [one year]

    The level of thought disorder will be investigated using the specific items of the Positive And Negative Syndrome Scale (PANSS; Kay et al., 1987) Minimum score 1 Maximum score 7

Secondary Outcome Measures

  1. cannabis use [one year]

    cannabis use (yes vs. no; i.e., the group factor)

  2. Delta-9 tetrahydrocannabinol (THC) concentration [one year]

    Concentrations of Delta-9 tetrahydrocannabinol in the cannabis usually smoked

  3. Cannabidiol (CBD) concentration [one year]

    Concentration of cannabidiol in the cannabis usually smoked

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Aged between 18 and 65

  • Meeting the DSM-5 criteria for schizophrenia

  • "Cannabis user" group: - Smoking at least two days per week during the previous months

  • Displaying positive urine screen for cannabis

  • "Non-cannabis user" group: - No episode of cannabis smoking during the previous month

  • Negative urine screen for cannabis + no lifetime criteria for cannabis use disorder (assessment by an addiction specialist).

Exclusion Criteria:
  • Current criteria for axis-1 psychiatric disorder other than schizophrenia

  • Current criteria for any other substance use disorder except for nicotine use disorder

  • Any contraindication for MRI

  • Tutorship or curatorship

  • Pregnant or lactating woman

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Le Vinatier Bron Auvergne Rhone Alpes France 69678 cedex

Sponsors and Collaborators

  • Hôpital le Vinatier

Investigators

  • Principal Investigator: Benjamin ROLLAND, MD, PhD, CH LE VINATIER
  • Study Director: Guillaume SESCOUSSE, MD, CH LE VINATIER

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT03608137
Other Study ID Numbers:
  • 2018-A00062-53
First Posted:
Jul 31, 2018
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hôpital le Vinatier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022